METHOD FOR PREPARING A GALENIC FORM FOR ORAL ADMINISTRATION BY LYOPHILIZATION OF AN OIL-IN-WATER EMULSION

摘要

This invention is concerned with a method for preparing a novel porous galenic form by lyophilization of an oilin-water emulsion containing at least one pharmaceutically active ingredient, which comprises the following steps : a) preparation of the lipid phase by stirring at a tempe rature lower than or equal to 80.degree.C so as to mix all the lipid-phase components, the lipid phase thus prepared being in the liquid state ; b) preparation of the aqueous phase, which comprises at least one substance selected from the group consisting of organic fillers and thickening agents, by stirring at a temperature lower than or equal to 80.degree.C so as to mix the water and the other components of the aqueous phase ; c) preparation of an emulsion under stirring at a tempera ture within the range of 10.degree.C to 80.degree.C by introducing the liquid lipid phase into the aqueous phase so as to ensure that the resulting emulsion is homogeneous ; d) distribution of the resulting mixture into alveolar packs ; e) freezing of the contents of the alveolar packs at a temperature within the range of -20.degree.C to -50.degree.C followed by lyophilization of said contents under a pressure within the range of approximately 80 Pa to approximately 0.13 Pa with a heat supply such that the temperature of the treated mass is always lower than the initial melting temperature of said mass ; the parmaceutically active substance being introduced prior to step d), if necessary by fractions. The invention also relates to the galenic form obtained in accordance with this method and constituting a novel industrial product.